Mechanism Of Stent Thrombosis (MOST) Study (Most)
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|ClinicalTrials.gov Identifier: NCT01410539|
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Stent Thrombosis Platelet Thrombus||Device: OCT guided PCI Drug: OCT guided medical therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry|
|Study Start Date :||January 2010|
|Primary Completion Date :||August 2011|
|Study Completion Date :||October 2011|
Experimental: Stent Thrombosis
Consecutive patients with stent thrombosis with stent strut assessment by OCT
Device: OCT guided PCI
OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).
Active Comparator: Controls
Control subjects without stent thrombosis from the RHR OCT database
Drug: OCT guided medical therapy
OCT guided medical therapy. Tailored antiplatelet therapy.
- Percentage of uncovered stent struts [ Time Frame: After thrombectomy ]The percentage of uncovered stent struts by OCT in patients with subacute stent thrombosis (either DES and BMS) and the percentage of uncovered stent struts in patients with late (after one month) and very late thrombosis of DES.
- Percentage of malapposed stent struts [ Time Frame: After Thrombectomy ]The percentage of malapposed stent struts by OCT in patients with subacute thrombosis of DES and BMS and the percentage of malapposed stent struts by OCT in patients with late and very late thrombosis of DES.
- Percentage of patients with high residual platelet reactivity [ Time Frame: Baseline ]The percentage of patients with residual platelet reactivity (RPR) to ADP and arachidonic acid identified by values ≥ 240 P2Y12 reaction units (PRU) and ≥ 550 aspirin reaction units (ARU), respectively,. during aspirin and clopidogrel therapy or in which one or both the antiplatelet drugs have been interrupted.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410539
|Careggi Hospital, Department of Hearth and Vessels|
|Study Chair:||David Antoniucci, MD||Careggi Hospital, Division of Invasive Cardiology|
|Principal Investigator:||Francesco Prati, MD||Rome Heart Research|